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| Sponsor: | Morphotek |
|---|---|
| Information provided by: | Morphotek |
| ClinicalTrials.gov Identifier: | NCT00849667 |
Purpose
This research is being done to find out if Carboplatin and Taxane works better alone or when given with an experimental drug called MORAb-003(farletuzumab) in subjects with first platinum sensitive relapsed ovarian cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer |
Drug: MORAb-003 (farletuzumab) Drug: 0.9% Saline |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Weekly MORAb-003 in Combination With Carboplatin and Taxane in Subjects With Platinum-sensitive Ovarian Cancer in First Relapse |
| Estimated Enrollment: | 1080 |
| Study Start Date: | March 2009 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Carboplatin and taxane with MORAb-003 1.25 mg/kg
|
Drug: MORAb-003 (farletuzumab)
MORAb-003 1.25 mg/kg infusions will take place weekly during combination therapy and then as single agent maintenance until progression.
|
|
Active Comparator: 2
Carboplatin and taxane with MORAb-003 2.5 mg/kg
|
Drug: MORAb-003 (farletuzumab)
MORAb-003 2.5mg/kg infusions will take place weekly during combination therapy and then as single agent maintenance until progression.
|
|
Placebo Comparator: 3
Carboplatin and taxane with Placebo
|
Drug: 0.9% Saline
0.9% infusions will take place weekly during combination therapy and then as single agent maintenance until progression.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Susan C Weil, MD, FACP | 877-327-1311 |
Show 333 Study Locations
More Information
| Responsible Party: | Susan Weil, M.D. /Study Medical Monitor, Morphotek, Inc |
| ClinicalTrials.gov Identifier: | NCT00849667 History of Changes |
| Other Study ID Numbers: | MORAb003-004 |
| Study First Received: | February 13, 2009 |
| Last Updated: | August 19, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
ovarian cancer relapsed ovarian cancer Platinum-sensitive Ovarian Cancer |
|
Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female |
Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Carboplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |